Move over, Johnson & Johnson's
Yesterday, a Food and Drug Administration advisory panel agreed that AstraZeneca's
The FDA doesn't have to follow the panel's recommendation, but since the drugs are already approved to treat adults, it seems likely that the agency will follow its panel's advice. The FDA may require the companies to establish a Risk Evaluation and Mitigation Strategy to ensure that doctors only prescribe the drug to the right patients, but that's a minor issue.
Antipsychotics are big business. Even without being able to market their drugs to kids -- although some young patients probably take the drugs off-label -- AstraZeneca has managed to sell $4.4 billion worth of Seroquel, while Lilly's Zyprexa sales have reached nearly $4.7 billion.
The companies don't break out off-label sales to minors, but according to pharmacy benefit manager Medco Health Solutions
An Rx for further Foolishness:
- The recession is (almost) over! Now what?
- Up 58% on no news? What's going on?
- It's finally time to buy these stocks.